Omeros Corporation
Unique Billing Code Allows Separate Payment for Omidria
SEATTLE, Oct. 30, 2014 – Omeros Corporation (NASDAQ: OMER) announced today that it has received transitional pass-through status for its lead product Omidria™ (phenylephrine and ketorolac injection) 1%/0.3% from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Approved earlier this year by the U.S. Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens replacement (ILR), Omidria is the only FDA-approved product for intraocular administration that prevents intraoperative miosis (pupil constriction) and reduces postoperative pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients. A large and growing market, cataract and other ILR procedures are among the most common surgical procedures performed in the U.S. with approximately four million expected in 2015.
Transitional pass-through status will allow ambulatory surgery centers and other outpatient facilities to bill Medicare and other insurance providers for Omidria using a temporary Healthcare Common Procedure Coding System (HCPCS) code unique to Omidria. Pass‑through status allows for separate payment for new drugs and other medical technologies that meet specific clinical-value and cost requirements. Pass‑through remains in effect for a period of two to three years, after which time CMS and other insurance providers make a new reimbursement determination. Pass‑through status for Omidria will become effective on January 1, 2015, and reimbursement will be based on the product's wholesale acquisition cost of between $400 and $500 per single-use vial.
"We are pleased with CMS's decision to grant pass-through for Omidria," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Pass-through status should streamline the billing and reimbursement process for facilities that use Omidria and could accelerate adoption of the product across cataract and other intraocular lens procedures. Coincident with this new clarity on reimbursement, our commercial team is in the process of adding the second wave of sales representatives, and we plan to launch Omidria no later than early 2015."
Important Risk Information for Omidria™
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two to 24 percent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Omidria™ must be diluted prior to use. Omidria is not approved for use in children.